Job Title:  Senior Regulatory Specialist

The Senior Regulatory Specialist is a full-time role vital to ensure safe and effective products are available in Reichert’s desired markets.  Medical device experience (Class I, II Active Device), project management, communication, judgment, and the ability to learn from others are key assets for this position.

How you will make an impact:

• Participate in compliance audits, customer audits, 3rd party regulatory audits and vendor audits; conduct internal audits of the Quality Management System as necessary.
• Develop and submit applications for product approval/registration for global markets. Duties are broad and require convincingly addressing questions and negotiating solutions until registrations are received. Then ensure continuation of registration or re-registration in desired markets. Needs may include updating device labeling, managing document translations, communicating and refining company processes, and interfacing with distributors, regulatory bodies and consultants.
• Candidate should have the ability to work with complex teams and foreign companies, with cultural differences. Ability to read, analyze, and interpret common scientific, technical journals and legal documents.
• Prepare EU MDR Technical Documentation.
• Participate on product development project teams and provides advice and direction on registration requirements. Including determination of new product regulatory classifications and definition of specifications to ensure product is developed with strategy in line with company goals and to maximize successful launch in intended markets.
• Review and approve test reports, clinical evaluations, and similar documentation in support of device compliance and registrations.
• Coordinate with 3rd party laboratories and accrediting bodies in product development and maintenance.
• Work with operations personnel to ensure on-going compliance with quality system requirements.
• Work with cross-functional teams to perform Risk Management activities and the compilation of and the maintenance of the Risk Management File.
• Must maintain knowledgeable, collaborative and effective interaction with Production, Research & Development, Product Management, and Engineering teams to proactively advance QMS as required to support world class manufacturing operations, and to communicate our QMS and products to outside bodies.
• Ensure labeling provided with devices, including marking, packaging, user documentation, and marketing communications are compliant with relevant regulations and norms.
• Ensure engineering changes are properly validated assessed for risk as required by regulation and that contractual and safety obligations to affected parties and approving bodies are addressed before implementation.
• Assist Sales in preparing regulatory documentation for international dealers, including determining local statutes, and defining contractual requirements.  Produce regulatory documentation as required to authorized international dealers to enable global sales. Including generation of CoA / CoC documentation and customer required documents as needed.
• Support post market activities associated with reporting, vigilance, product recalls etc.
• Self-directed continued education and training in current and evolving regulations
• Additional duties as assigned.

What you will bring to the role:

• BS degree in a technical/professional discipline or at least 3-7 years of experience and knowledge in the quality or regulatory field for medical devices; MS and or MBA degree preferred.
• Working knowledge of medical device Quality Systems including ISO 13485:2016, MDSAP (13485), EU MDR 2017/745, Annex IX , US FDA CFR 21 820. Internal auditing experience for these systems preferred.
• Working knowledge of relevant national and international standards and processes for compliance (3rd parties, labs, audits, etc.) as applicable to electrical and medical compliance systems, including those required for FDA clearance and for CE marking (i.e. MDR, EMC, IVDR, RoHS.)
• Working knowledge of risk management process (such as ISO 14971:2019) and hands-on experience in risk management tools (FTA, FMEA, Risk Assessment, etc.).
• Strong communication skills, including ability to speak and write convincingly and attention to detail in all documentation.
• Ability to read engineering drawings and laboratory test reports.
• Preferred experience with international business. Multilingual abilities preferred.
• Computer competency in Word, Excel, Power Point, eQMS databases.
• Desired professional associations, certifications, or licenses within the Safety, Quality Assurance, or Medical Regulatory industries, expected within 2 years of position acceptance.

Working Conditions:

• Regularly required to sit for long periods or move about the facility.  May be exposed to shop elements such as noise, dust and odors.
• Required to use computer, telephone, and office equipment.
• Some travel may be required for this position, expect to be <10% annually